Investigator Initiated Clinical Study to Explore the Efficacy and Safety of Human Placenta Hydrolysate in the Chronic Fatigue Patients
NCT ID: NCT01742013
Last Updated: 2013-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
78 participants
INTERVENTIONAL
2013-01-31
2013-09-30
Brief Summary
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This study aims to investigate the safety and efficacy of GCJBP Laennec Inj. (Human placenta hydrolysate) in the chronic fatigue patients through a randomized controlled tial.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
NaCl 0.9%, s.c., 4ml (2ml x 2), 3 times per a week, 6 weeks
Placebo
Comparator
GCJBP Laennec Inj.
GCJBP Laennec Injection,s.c., 4ml(2ml x 2)/day, 3 times per a week, 6 weeks
GCJBP Laennec Inj.
Test drug
Interventions
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GCJBP Laennec Inj.
Test drug
Placebo
Comparator
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Given written informed consent
* Male or female aged between 20 and 65
* Patient who can read and answer to written questionnaires
* Patient who agrees to visit clinic for study drug injection 3 times per a week for 6 weeks
Exclusion Criteria
* Patient who is pregnant or childbearing potential female patient who does not consent for contraception during the study
* Patient who has a hypersensitivity provoked by study drug or others drived from animals
* Patient who has been received with any human placenta product for 6 months before study participation
* Abnormal liver function
* Abnormal renal function
* Back Depression Inventory (BDI) II is more than 29
* Underlying disease/conditions, in the investigator's judgment, which will be unable to participate in the study
20 Years
65 Years
ALL
No
Sponsors
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Ajou University School of Medicine
OTHER
Green Cross Corporation
INDUSTRY
Symyoo
INDUSTRY
Ho Cheol Shin, M.D., Ph.D.
OTHER
Responsible Party
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Ho Cheol Shin, M.D., Ph.D.
Professor
Principal Investigators
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Ho Cheol Shin, M.D., Ph.d.
Role: PRINCIPAL_INVESTIGATOR
Kangbuk Samsung Hospital
Locations
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Kangbuk Samsung Hospital
Seoul, , South Korea
Ajou University Hospital
Suwon, , South Korea
Countries
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Other Identifiers
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Laennec-IIT
Identifier Type: -
Identifier Source: org_study_id